Food and Drug Administration

Blood Products Advisory Committee

November 4, 2005

Slides

Serious Adverse Events Following Falsely Elevated Glucose Measurements Resulting From Administration of an IGIV Product Containing Maltose (HTM) (PPT)

Serious Adverse Events Following Falsely High Glucose Measurements Resulting From Administration of an IGIV Product Containing Maltose, L Pierce, MD, FDA (HTM) (PPT)

Serious Adverse Events Following Falsely Elevated Blood Glucose Measurements Resulting From Administration of an IGIV Product Containing Maltose, Patricia Bernhadt MT (ASCP) (HTM) (PPT)

The False Interpretation of Maltose as Glucose by Some Types of Glucose Testing Systems,Octapharma (HTM) (PPT)

Heterogeneity of Commercial Alpha-1-Proteinase Inhibitor (Human) [A1PI] Products - Implications for Longer-Term Safety and Efficacy?, Andrew Shrake, PhD, FDA (HTM) (PPT)

Observations on Marketed Alpha-1-Proteinase Inhibitor Products, Ewa Marszal, PhD, FDA (HTM) (PPT)

Identification and Possible Implications of a Human Plasma Purified Anodal Variant of Alpha-1-Antitrypsin, Mark Brantly, MD, University of Florida (PDF)

Characterization of ARALAST Compared to Other A1PI Preparations, Hans Schwarz, MD, Baxter (HTM) (PDF)

Alpha-1 Proteinase Inhibitor (Human) Product (A1PI) Safety Reporting, Tina Khoe, MD, MPH, et. al. (HTM) (PPT)

Postmarketing Clinical Studies of A1PL PRoducts, L. Piece, MD, FDA (HTM) (PPT)

Licensed Biological Products With Structural Heterogeneity, Andrew Chang, PhD, FDA (HTM) (PPT)

Presentation by Kurt Brorson, PhD, FDA (HTM) (PPT)

Open Public Hearing

Presentation by Talecris (HTM) (PPT)

Presentation by ZLB Behring (PDF) (PPT)